ATRA for Management of Primary ITP
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
Where in China
- Peking University Institute of hematology, People's HospitalBeijing, ChinaContact: Xiaohui ZhangNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Peking University People's Hospital
- Trial code
- NCT07597395
- Record updated
- 19 May 2026
- Original description
A multicenter, randomized, double-blind placebo-controlled study to report the efficacy and safety of all-trans etinoic acid compared to placebo for the treatment of adults with corticosteriod-resistant/relapsed primary immune thrombocytopenia (ITP).Read full original descriptionShow less
All-trans Retinoic Acid for Management of Primary Immune Thrombocytopenia : a Randomized, Double-blind, Placebo-controlled Study
A multicenter, randomized, double-blind placebo-controlled study to report the efficacy and safety of all-trans etinoic acid compared to placebo for the treatment of adults with corticosteriod-resistant/relapsed primary immune thrombocytopenia (ITP).
Inclusion: Primary ITP if aged ⩾18 years; With an average of two platelet counts ⩾1 day apart of <30×10\^9/L during screening and no single platelet count >35×10\^9/L within 2 weeks before study treatment; Patients who have previously received at least one first-line standard therapy for ITP (corticosteroid and/or intravenous immunoglobulin) with unsustained efficacy, relapse, intolerance to standard therapy, or insufficient response.
Exclusion: With a history of symptomatic herpes zoster infection within 12 weeks prior to screening; Evidence of active tuberculosis; or previous evidence of active tuberculosis without appropriate and documented treatment; or household contact with patients with active tuberculosis without appropriate and documented tuberculosis prophylaxis; Receipt of live vaccines within the past 12 weeks, or planned live vaccination during the study period; Prior ATRA therapy; Patients with other diseases were undergoing treatment with immunosuppressants; History or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, neurological, neuropsychiatric or any other severe and/or unstable diseases that, in the opinion of the investigator, may pose an unacceptable risk with the investigational product or interfere with the interpretation of study data; With active malignancy or a history of malignant tumor; Having experienced severe bacterial, viral, fungal or parasitic infection within the past 4 weeks; Active or chronic HBV, HCV or HIV infection; History of solid organ transplant or planned surgery; Myelodysplastic syndrome, aplastic anemia or myelofibrosis; History or presence of myocardial infarction, unstable ischemic heart disease, stroke, or NYHA Class IV heart failure; AST > 2 times the upper limit of normal (ULN), ALT > 2×ULN, TBIL ≥ 1.5×ULN; WBC < 2500/µL, neutrophil count < 1200/µL, lymphocyte count < 750/µL, hemoglobin < 9 g/dL; eGFR < 50 mL/min/1.73m²; Pregnant or lactating women, and who were possibly pregnant, planning to become pregnant, or who had partners planning to become pregnant; Clinically significant thromboembolic events within the past 24 weeks, or ongoing anticoagulant treatment, who are deemed ineligible for the study by the investigator; Other patients deemed unsuitable for enrollment in this study by the investigator.